Mealey's Drugs & Devices : Mealey's : Legal News & Analysis

Mealey's Drugs & Devices

August 25, 2025
Texas, Florida Ask To Intervene In Mifepristone Case To Protect States’ Interests

AMARILLO, Texas — Texas and Florida say the three states that intervened in a case originated by a group of antiabortion advocates challenging the U.S. Food and Drug Administration’s approval of the abortion drug mifepristone can no longer represent their interests and on Aug. 22 moved in a Texas federal court for permission to intervene.
August 22, 2025
Compounding Pharmacies: Judge Erred In Allowing Drug’s Removal From Shortage List

NEW ORLEANS — Upholding a Texas federal judge’s “wayward view” in granting summary judgment to the U.S. Food and Drug Administration and Eli Lilly and Co. in a dispute over whether the agency properly determined that the shortage of tirzepatide, a drug for diabetes and weight loss, would “end judicial review of agency action as it has existed for generations,” companies representing the interests of drug compounders tell the Fifth Circuit U.S. Court of Appeals in an opening brief made public on Aug. 21.
August 21, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 21, 2025
More States Tell FDA That Mifepristone Restrictions Are Unneeded, Should Be Removed

A coalition of states on Aug. 20 submitted a citizen petition to the U.S. Food and Drug Administration urging the agency to remove the Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone, one of the two drugs prescribed for medication abortions, joining four other states that filed a similar petition in June.
August 21, 2025
N.Y. Federal Judge Finds Claims In Defective Heart Device Case Are Preempted

NEW YORK — A New York federal judge granted a motion to dismiss a lawsuit filed by the estate of a woman who allegedly died as a result of heart defibrillator device failing to function as intended after finding that the claims are preempted by federal law.
August 21, 2025
Hologic Loses Bid For Summary Judgment In Bellwether BioZorb Cases

BOSTON — The federal judge in Massachusetts overseeing a group of cases in which women allege that an implanted radiographic marker used to mark soft tissue sites during cancer treatment was defective and caused injuries denied a motion for summary judgment filed by the device manufacturer, which argued that two bellwether plaintiffs failed to prove causation.
August 20, 2025
COMMENTARY: Pharmaceutical Ad Proposals Target Wrong Malady

By Mark A. Behrens and Cary Silverman
August 20, 2025
Express Scripts: Order In W.Va. Opioid Case Violates Constitutional Rights

WHEELING, W.Va. — A pharmacy benefits manager facing allegations that its actions contributed to an “oversupply” of prescription opioids throughout West Virigina asks a federal court in the state to reconsider its order to expedite a two-phase bench trial on public nuisance liability.
August 20, 2025
GLP-1 MDL Judge Partially Grants Drug Makers’ Motion To Dismiss Master Complaint

PHILADELPHIA — The Pennsylvania federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries largely denied a motion to dismiss certain claims from a master long-form complaint.
August 19, 2025
Delaware High Court Affirms Ruling In Insurers’ Favor In Opioid Coverage Dispute

WILMINGTON, Del. — The Delaware Supreme Court on Aug. 18 affirmed a lower court’s ruling that denied CVS Health Corp.’s motion for partial summary judgment and granted its insurers’ motion for partial summary judgment in their lawsuit disputing coverage for 218 underlying opioid lawsuits, agreeing with the lower court that, under ACE American Insurance Co. v. Rite Aid Corp., the underlying lawsuits fail to seek damages because of any specific bodily injury or damage to any specific property to trigger coverage.
August 19, 2025
D.C. Circuit: FDA Erred In Denying Drug Application Without Holding Hearing

WASHINGTON, D.C. — The U.S. Food and Drug Administration erred in refusing to hold a hearing before denying Vanda Pharmaceuticals Inc.’s application for approval to market the drug tasimelteon as a treatment for jet lag, the District of Columbia Circuit U.S. Court of Appeals said.
August 19, 2025
PBM Asks For Order Barring Ex Parte Communications After Email Error In Opioid MDL

CLEVELAND — A pharmacy benefit manager (PBM) involved in the opioid multidistrict litigation pending in a federal court in Ohio moved for an order “prohibiting ex parte communications between the Special Masters and the Court regarding the Special Masters’ rulings.”
August 18, 2025
Court Told Excluded Expert Penned Study Linking Acetaminophen With Autism/ADHD

NEW YORK — An attorney representing parents who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder (ADHD) but saw their claims dismissed after a New York federal judge in two separate orders excluded their causation experts filed a letter on Aug. 15 with the Second Circuit U.S. Court of Appeals, alerting the court to a recent study co-authored by one of its experts that linked the drug to the disorders.
August 15, 2025
Woman Sues Cartiva For Faulty Toe Implant, Says Company Hid Information

PITTSBURGH — A woman alleges that the manufacturer of a synthetic cartilage implant (SCI) device used to treat arthritis in a toe joint misled the public and the U.S. Food and Drug Administration about the safety of the device, which caused the woman to suffer pain after the device failed.
August 15, 2025
Parties Debate If Theranos’ Balwani’s Appeal Warrants 2nd Look By 9th Circuit

SAN FRANCISCO — Former Theranos Chief Operating Officer Ramesh “Sunny” Balwani argues that the government’s opposition to his motion filed in the Ninth Circuit U.S. Court of Appeals for a rehearing or a rehearing en banc of the court’s decision that the government’s failure to correct false testimony during his criminal trial does not warrant a new trial “underscores the need for” a review.
August 14, 2025
Singapore Court Maintains Freeze Of Bioscience Company Assets Pending Arbitration

SINGAPORE — A judge of the Singapore International Commercial Court granted an ex parte application by a Danish company brought against a Singaporean bioscience company and its founder for a worldwide asset freeze pending arbitration in New York regarding an $830 million dispute over a drug for hypertension and kidney disease.
August 14, 2025
Texas Says Lilly Violated State Law To Induce Providers To Prescribe Its Drugs

MARSHALL, Texas — Texas has sued Eli Lilly & Company Inc. in a state court, alleging that the pharmaceutical company violated the Texas Health Care Program Fraud Prevention Act (THFPA) through programs used to induce providers to prescribe its medications, including its GLP-1 medications Mounjaro and Zepbound.
August 13, 2025
8th Circuit Finds District Court Did Not Fully Consider Jurisdiction Arguments

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals remanded a product liability case involving an allegedly defective medical device for a district court to conduct a new forum non conveniens analysis after finding that the court erred in granting a motion to dismiss.
August 13, 2025
Judge Finds Women’s Claims On Defective Birth Control Device Are Preempted

ATLANTA — A Georgia federal judge agreed with the manufacturer and distributor of a birth control device and a parent company, which argued that claims filed by women who allege that the device caused injuries are preempted by federal law.
August 12, 2025
Depo-Provera MDL Judge Rejects Bid To Modify Common Benefits Guidelines

PENSACOLA, Fla. — A Florida federal judge denied a motion to modify an order, which established common benefit preliminary procedures and guidelines, filed by a law firm that represents one plaintiff in the Depo-Provera multidistrict litigation, a group of cases alleging that a long-lasting injectable contraceptive caused women to develop intracranial meningiomas, a type of brain tumor.
August 12, 2025
Parties Ordered To Explain Failure To Provide Pharmacy Records In Suboxone MDL

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation ordered certain defendants to show cause why they should not be held in contempt for failing to comply with a discovery order.
August 07, 2025
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 07, 2025
False Advertising Suit Against IVF Embryo-Testing Company Dismissed

OAKLAND, Calif. — A California federal judge dismissed a putative class action filed by two women against a company that advertises itself as testing embryos obtained through in vitro fertilization (IVF) for abnormalities before implantation, finding that the plaintiffs’ claims that the company misrepresented the accuracy of its tests in violation of California’s unfair competition law (UCL) and other laws were not pleaded with sufficient specificity.
August 07, 2025
Cobb County, Ga., Publix Settle Opioid Claims Involving Public Nuisance Laws

ATLANTA — A case filed by a county in Georgia against a supermarket chain that was once selected as a bellwether case in the nationwide opioid multidistrict litigation and was the subject of a dispute on whether questions on how the state’s public nuisance laws apply in the MDL should be certified to the state’s Supreme Court has settled, according to an order by a Georgia federal judge.
August 06, 2025
Pa. Federal Judge Holds Off On Ordering Sanctions Against Firm In Thalidomide Cases

PHILADELPHIA — A federal judge in Pennsylvania on Aug. 5 ruled that he will grant a law firm and its attorneys, who represented plaintiffs who claimed that they suffered birth defects as a result of their mothers being given the drug thalidomide to treat morning sickness during their pregnancies, “the opportunity to be heard once before” he decides if sanctions are warranted for the firm’s alleged misconduct during the litigation, which began in 2011.